Effects of Saline on Circulation in Children
- Conditions
- Pulmonary Hypertensive Crisis
- Interventions
- Drug: 7.2% NaClDrug: 0.9% NaCl
- Registration Number
- NCT01668277
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
- Age > 2 years
- Plasma Na < 130 mmol/l or >150 mmol/l
- Refusal of consent
- An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
- Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ml/kg 7.2% NaCl 7.2% NaCl The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. 3 ml/kg 0.9% NaCl 0.9% NaCl The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. 20 ml/kg 0.9% NaCl 0.9% NaCl The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
- Primary Outcome Measures
Name Time Method Systemic Vascular Resistance Index Change from Baseline in Systemic Vascular Resistance Index after 1 hour Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Cardiac Index Change from Baseline in Cardiac Index after 1 hour Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.
Pulmonary Vascular Resistance Index Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
- Secondary Outcome Measures
Name Time Method Blood Gas Average over 1 hour Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer
Plasma Volume Average over 1 hour Effect on plasma volume calculated from the change in blood hemoglobin
Atrial Natriuretic Peptide Average over 1 hour Effect on atrial natriuretic peptide
Trial Locations
- Locations (2)
Hospital For Sick Children
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hospital For Sick Children🇨🇦Toronto, Ontario, Canada